CHOLESTYRAMINE powder, for suspension

Country: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

CHOLESTYRAMINE (UNII: 4B33BGI082) (CHOLESTYRAMINE - UNII:4B33BGI082)

Fáanlegur frá:

Zydus Lifesciences Limited

Stjórnsýsluleið:

ORAL

Gerð lyfseðils:

PRESCRIPTION DRUG

Ábendingar:

1) Cholestyramine for oral suspension is indicated as adjunctive therapy to diet for the reduction of elevated serum cholesterol in patients with primary hypercholesterolemia (elevated low density lipoprotein [LDL] cholesterol) who do not respond adequately to diet. Cholestyramine for oral suspension may be useful to lower LDL cholesterol in patients who also have hypertriglyceridemia, but it is not indicated where hypertriglyceridemia is the abnormality of most concern. Therapy with lipid-altering agents should be a component of multiple risk factor intervention in those individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Treatment should begin and continue with dietary therapy specific for the type of hyperlipoproteinemia determined prior to initiation of drug therapy. Excess body weight may be an important factor and caloric restriction for weight normalization should be addressed prior to drug therapy in the overweight. Prior to initiating therapy with cholestyramine for oral suspension secondary causes of hypercholesterolemia (e.g., poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinemias, obstructive liver disease, other drug therapy, alcoholism), should be excluded, and a lipid profile performed to assess Total cholesterol, HDL-C, and triglycerides (TG). For individuals with TG less than 400 mg/dL (< 4.5 mmol/L), LDL-C can be estimated using the following equation:- LDL-C = Total cholesterol – [(TG/5) + HDL-C] For TG levels > 400 mg/dL, this equation is less accurate and LDL-C concentrations should be determined by ultracentrifugation. In hypertriglyceridemic patients, LDL-C may be low or normal despite elevated Total-C. In such cases cholestyramine for oral suspension may not be indicated. Serum cholesterol and triglyceride levels should be determined periodically based on NCEP guidelines to confirm initial and adequate long-term response. A favorable trend in cholesterol reduction should occur during the first month of cholestyramine for oral suspension therapy. The therapy should be continued to sustain cholesterol reduction. If adequate cholesterol reduction is not attained, increasing the dosage of cholestyramine for oral suspension or adding other lipid-lowering agents in combination with cholestyramine for oral suspension should be considered. Since the goal of treatment is to lower LDL-C, the NCEP4 recommends that LDL-C levels be used to initiate and assess treatment response. If LDL-C levels are not available then Total-C alone may be used to monitor long-term therapy. A lipoprotein analysis (including LDL-C determination) should be carried out once a year. The NCEP treatment guidelines are summarized below. * Coronary heart disease or peripheral vascular disease (including symptomatic carotid artery disease). ** Other risk factors for coronary heart disease (CHD) include: age (males ≥ 45 years; females ≥ 55 years or premature menopause without estrogen replacement therapy); family history of premature CHD; current cigarette smoking; hypertension; confirmed HDL-C < 35 mg/dL (< 0.91 mmol/L); and diabetes mellitus. Subtract one risk factor if HDL-C is ≥ 60 mg/dL (≥ 1.6 mmol/L). Cholestyramine for oral suspension monotherapy has been demonstrated to retard the rate of progression2,3   and increase the rate of regression3 of coronary atherosclerosis. 2) Cholestyramine for oral suspension is indicated for the relief of pruritus associated with partial biliary obstruction. Cholestyramine for oral suspension has been shown to have a variable effect on serum cholesterol in these patients. Patients with primary biliary cirrhosis may exhibit an elevated cholesterol as part of their disease. Cholestyramine for oral suspension is contraindicated in patients with complete biliary obstruction where bile is not secreted into the intestine and in those individuals who have shown hypersensitivity to any of its components.

Vörulýsing:

Cholestyramine for Oral Suspension, USP is available in cans containing 378 grams and in cartons of sixty 9 gram pouches. Four grams of anhydrous cholestyramine resin are contained in 9 grams of cholestyramine for oral suspension, USP. The 378 grams can includes a 15 cc scoop. The scoop is not interchangeable with scoops from other products. NDC 70771-1105-1           Can, 378 grams NDC 70771-1105-2           Carton of 60, 9 grams pouches Store between 20  to 25 C (68  to 77 F). [See USP Controlled Room Temperature]. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Leyfisstaða:

Abbreviated New Drug Application

Vara einkenni

CHOLESTYRAMINE- CHOLESTYRAMINE POWDER, FOR SUSPENSION
ZYDUS LIFESCIENCES LIMITED
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CHOLESTYRAMINE FOR ORAL SUSPENSION, USP
RX ONLY
DESCRIPTION
Cholestyramine for oral suspension USP, the chloride salt of a basic
anion exchange
resin, a cholesterol lowering agent, is intended for oral
administration. Cholestyramine
resin is quite hydrophilic, but insoluble in water. The cholestyramine
resin in
cholestyramine for oral suspension, USP is not absorbed from the
digestive tract. Four
grams of anhydrous cholestyramine resin is contained in 9 grams of
cholestyramine for
oral suspension, USP. It is represented by the following structural
formula:
Cholestyramine for oral suspension, USP contains the following
inactive ingredients:
citric acid, d & c yellow # 10 aluminum lake, flavor (natural and
artificial orange, natural
and artificial vanilla), fd & c yellow # 6 aluminum lake, propylene
glycol alginate, sucrose
and xanthan gum.
ACTIONS/CLINICAL PHARMACOLOGY
Cholesterol is probably the sole precursor of bile acids. During
normal digestion, bile
acids are secreted into the intestines. A major portion of the bile
acids is absorbed from
the intestinal tract and returned to the liver via the enterohepatic
circulation. Only very
small amounts of bile acids are found in normal serum.
Cholestyramine for oral suspension resin adsorbs and combines with the
bile acids in
the intestine to form an insoluble complex which is excreted in the
feces. This results in
a partial removal of bile acids from the enterohepatic circulation by
preventing their
absorption.
The increased fecal loss of bile acids due to cholestyramine for oral
suspension
administration leads to an increased oxidation of cholesterol to bile
acids, a decrease in
administration leads to an increased oxidation of cholesterol to bile
acids, a decrease in
beta lipoprotein or low density lipoprotein plasma levels and a
decrease in serum
cholesterol levels. Although in man, cholestyramine for oral
suspension produces an
increase in hepatic synthesis of cholesterol,